| Popis: |
This chapter illustrates the concept of multivariate statistical process monitoring (MSPM) with data from a biopharmaceutical drug product lyophilization process. It provides the practitioner with steps needed for pretreatment of the data, modeling, and testing phases of the approach. The MSPM applied to the lyophilization process comprised three different models for the freezing, primary drying, and secondary drying steps using a commercially available software. In the presented example, the developed offline MSPM batch model helped diagnose issues with a batch manufactured at a later time using built-in features of the software which allows identification of the variables using their contribution to Hotelling’s T2 and distance to model X measures. |
